This manual provides essential guidance for the safe and effective use of the Prevena Plus 125 Therapy Unit, ensuring optimal wound healing and patient care.
1.1 Overview of the Prevena Plus 125 Therapy Unit
The Prevena Plus 125 Therapy Unit is a single-use, disposable device designed for negative pressure wound therapy. It features a 150 ml container with a graduated scale, a rechargeable battery, and a simple on/off button. The unit is intended for use in managing surgical incisions and wounds, promoting healing by applying negative pressure. It includes a Visicheck feature for leak detection and operates with audible alerts for status updates. The therapy unit is compact, portable, and designed for up to seven days of continuous use.
1.2 Importance of Following the Instruction Manual
Adhering to the Prevena Plus 125 Instruction Manual is crucial for ensuring safe and effective therapy. Proper usage prevents complications, optimizes wound healing, and maintains device functionality. The manual provides specific guidelines for application, operation, and troubleshooting, minimizing risks of leaks, alarms, and device malfunction. By following the instructions, users can ensure compliance with medical standards and achieve the best clinical outcomes for patients. Consultation with a clinician is recommended before application to address any specific patient needs or contraindications.
Installation and Setup of the Prevena Plus 125
Proper installation ensures the Prevena Plus 125 functions correctly. Insert the 150 ml container fully, aligning it with the graduated scale. Calibration and initial setup are essential for accurate operation.
2.1 Unpacking and Preparing the Device
Begin by carefully unpacking the Prevena Plus 125 Therapy Unit and its accessories. Inspect the device for any visible damage or defects. Ensure all components, including the 150 ml container, graduated scale, and power cord, are included. Wipe the exterior with a soft cloth to remove any debris. Press and hold the power button to initiate the unit’s power-on sequence. Allow the device to complete its self-check to ensure proper functionality before proceeding with further setup or use.
2.2 Inserting the 150 ml Container
To insert the 150 ml container, first ensure it is sterile and undamaged. Align the container’s locking mechanism with the unit’s receptor. Gently push the container into the unit until it clicks securely into place. Verify proper insertion by checking the unit’s display for confirmation. If the container is not fully inserted, the therapy unit will emit a warning alert. Ensure the container is locked to avoid leaks and maintain proper therapy function.
2.3 Understanding the Graduated Scale
The graduated scale on the 150 ml container measures fluid accumulation, marked in increments of approximately 50 cc/ml. Proper alignment of the container ensures accurate fluid level monitoring. Always verify the scale is visible and aligned with the unit’s receptor to avoid reading errors. The scale helps track therapy progress and determine when the container needs emptying. Ensure the container is securely locked to maintain accurate readings and prevent leaks during therapy. Proper use of the graduated scale is essential for effective therapy management.
2.4 Initial Power-On and Device Calibration
To initialize the Prevena Plus 125, plug in the device and press the power button. The unit will perform a self-test, indicated by LED lights. Ensure the 150 ml container is fully inserted and aligned. Calibration begins automatically upon power-on, ensuring accurate pressure settings. If calibration fails, check the container’s position and connections. Proper calibration is essential for therapy effectiveness. Follow all safety precautions during the process. Once calibrated, the unit is ready for use. Always refer to the manual for detailed calibration steps. Proper initialization ensures optimal therapy performance.
Application and Usage Guidelines
Follow these guidelines for proper application, ensuring the dressing is securely placed and the therapy unit is correctly activated for effective wound healing and patient comfort.
3.1 Preparing the Surgical Site
Before applying the Prevena Plus 125 dressing, ensure the surgical site is clean and dry. Remove any oils, lotions, or residual disinfectants. The skin around the incision should be free of moisture and any open wounds. Allow the skin to dry completely after cleaning to ensure proper adhesion. Clinicians or patients should inspect the area for any signs of irritation or infection. Follow specific instructions provided by healthcare professionals for preparing the site to maximize dressing effectiveness and promote healing. Proper preparation is crucial for optimal therapy results.
3.2 Applying the Prevena Dressing
Peel the backing from the Prevena dressing and align it with the surgical site. Press firmly to ensure proper adhesion, starting from the center and smoothing outward to avoid air pockets. Ensure the dressing is centered over the incision and adheres evenly to the surrounding skin. Use gentle pressure to secure the edges. Activate the Visicheck feature by double-pressing the on/off button to confirm proper application and seal. Follow the manufacturer’s guidelines for optimal placement and alignment to ensure effective therapy delivery.
3.3 Connecting the Dressing to the Therapy Unit
Attach the Prevena dressing to the therapy unit by aligning the connector with the unit’s port. Secure the connector firmly, ensuring it clicks into place. Verify the connection is tight to prevent leaks. Use the Visicheck feature to confirm proper attachment by double-pressing the on/off button. A confirmation tone or light indicates a secure connection. Refer to the manufacturer’s guidelines for specific instructions on aligning and locking the connector to ensure proper functionality and avoid any complications during therapy.
3.4 Activating the Therapy Unit
Press and hold the on/off button until the unit emits a confirmation tone and the display lights up. Release the button to initiate therapy. Ensure the device is in a stable position and the dressing is securely connected. The unit will begin applying negative pressure automatically. Use the Visicheck feature to confirm proper seal and function. If the unit does not activate, check connections and ensure the canister is properly locked. Refer to the manual for troubleshooting steps if issues persist.
Operating the Prevena Plus 125
Use the on/off button to control therapy, monitor progress via the display, and respond to alerts. Utilize the Visicheck feature to ensure proper function and address any issues promptly.
4.1 Understanding the On/Off Button
The on/off button is located on the front of the Prevena Plus 125 Therapy Unit, allowing easy control of therapy activation. Pressing the button once turns the unit on, initiating negative pressure therapy, while pressing it again deactivates the system. The button also doubles as an alert mute feature; holding it for three seconds silences audible alerts temporarily. Proper use ensures uninterrupted therapy and patient comfort. Always consult the manual or a clinician for guidance on operation.
4.2 Monitoring the Therapy Progress
Regular monitoring of the Prevena Plus 125 Therapy Unit ensures effective therapy delivery. Check the pressure indicator to confirm proper negative pressure levels and monitor battery life. The unit displays alerts for low battery, leaks, or therapy interruptions. Use the Visicheck feature to assess seal integrity by double-pressing the on/off button. Ensure the canister is securely locked to prevent leaks. Always refer to the manual or consult a clinician for guidance on interpreting alerts and maintaining optimal therapy performance.
4.3 Responding to Alerts and Alarms
The Prevena Plus 125 Therapy Unit features visual and audible alerts for low battery, leaks, or therapy interruptions. To silence an alarm, press and hold the mute button for three seconds. This action temporarily mutes the alert for two minutes. Address the underlying issue promptly, such as charging the battery or checking for leaks. Always follow the manual’s troubleshooting guide or consult a clinician to resolve issues and maintain uninterrupted therapy. Proper responses ensure patient safety and effective wound healing outcomes.
4.4 Using the Visicheck Feature
The Visicheck Feature on the Prevena Plus 125 helps verify the integrity of the therapy system. To activate it, double-press the On/Off button. The unit will then perform a quick check for leaks or system issues. If a “Marginal Leak Rate” alert appears, ensure the canister is securely locked into the unit. If the issue persists, refer to the troubleshooting section of the manual or consult a healthcare professional to resolve the problem and maintain effective therapy. This feature ensures proper function and optimal wound healing outcomes.
Maintenance and Troubleshooting
This section provides guidance on maintaining the Prevena Plus 125, including checking for leaks, replacing the battery, and resolving common issues to ensure proper functionality.
5.1 Checking for Leaks
Regularly inspect the Prevena Plus 125 system for leaks to ensure proper function. Verify that the canister is securely locked into the therapy unit and all connections are tight. If a leak is detected, the unit will alert you with a warning. Check the dressing and tubing for any visible signs of air escaping. Ensure the dressing is properly sealed around the incision site. Refer to the manual for detailed steps on addressing leaks and maintaining system integrity for effective therapy. Promptly address any issues to prevent interruptions in treatment.
5.2 Replacing the Battery
To replace the battery in the Prevena Plus 125, first ensure the device is turned off. Locate the battery compartment, usually found on the underside or rear of the unit. Open the compartment and carefully remove the old battery. Insert a new alkaline or nickel-based battery, ensuring proper alignment with the terminals. Close the compartment securely and turn the device on to test functionality. Dispose of the old battery safely. Refer to the manual for specific battery type recommendations and safety guidelines to maintain optimal performance and prevent damage.
5.3 Resolving Common Issues
Common issues with the Prevena Plus 125 may include alerts, alarms, or therapy interruptions. If an alert occurs, refer to the device’s display for specific error codes or messages. For a marginal leak rate, ensure the canister is securely locked and all connections are tight. If issues persist, restart the device or consult the troubleshooting section. Always follow the manufacturer’s guidelines for resolving problems. If unresolved, contact a healthcare professional or the manufacturer’s support team for assistance. Proper resolution ensures continued effective therapy and patient safety.
5.4 Cleaning the Therapy Unit
Cleaning the Prevena Plus 125 Therapy Unit is essential for maintaining proper function and hygiene. Use a soft, damp cloth with mild detergent to wipe the exterior. Avoid harsh chemicals or submerging the unit in water. Do not clean internal components, as this may damage the device. Regular cleaning helps prevent contamination and ensures optimal performance. Always follow the manufacturer’s cleaning guidelines to maintain the unit’s integrity and patient safety. Proper maintenance extends the lifespan of the therapy unit and ensures effective therapy delivery.
Safety Precautions and Warnings
Always adhere to guidelines to avoid misuse. Consult instructions for contraindications and precautions. Ensure patient safety by proper use and handling of the therapy unit.
6.1 Contraindications for Use
The Prevena Plus 125 Therapy Unit is contraindicated for use on open wounds, necrotic tissue, or where cancerous cells are present. It is also not recommended for patients with active bleeding or those requiring high negative pressure settings. Always consult your healthcare provider to ensure proper patient selection and safe application of the therapy unit. Adherence to these guidelines is crucial to avoid complications and ensure effective wound management.
6.2 Warnings and Cautions
The Prevena Plus 125 Therapy Unit should be used with caution in patients with sensitive skin or allergies to medical adhesives. Avoid immersing the device in water, as it may damage electrical components. Do not use the unit near hyperbaric oxygen therapy environments or in areas with high electromagnetic interference. Ensure the therapy unit is used only as prescribed by a healthcare professional. Failure to follow these guidelines may result in compromised therapy outcomes or device malfunction. Always monitor for signs of adverse reactions during use.
6.3 Electromagnetic Compatibility
The Prevena Plus 125 Therapy Unit is designed to operate in controlled electromagnetic environments. It complies with international standards for medical devices, ensuring minimal disruption from external electronic sources. However, avoid using the device near strong magnetic fields or high-frequency equipment, as this may interfere with its operation. Always verify compatibility with other medical equipment in the vicinity to maintain safe and effective therapy delivery. Consult the manual for detailed specifications on electromagnetic compatibility requirements.
6.4 Hyperbaric Oxygen Therapy Compatibility
The Prevena Plus 125 Therapy Unit is contraindicated for use in hyperbaric oxygen therapy environments. Exposure to hyperbaric conditions may interfere with the unit’s functionality, potentially causing leaks or mechanical failure. To ensure safe operation, avoid using the device in hyperbaric chambers or high-pressure settings. Always consult the product’s instructions for use and seek guidance from a healthcare professional if such environments are part of the patient’s treatment plan. Proper precautions are essential to maintain therapy effectiveness and patient safety;
Patient Care and Monitoring
Regular monitoring ensures the Prevena Plus 125 operates effectively, supporting patient mobility and activities while maintaining therapy continuity and safety.
7.1 Caring for the Therapy Unit
Regularly inspect the Prevena Plus 125 for damage or leaks. Clean the unit with a damp cloth, avoiding harsh chemicals. Ensure the battery is charged as instructed and store the device in a dry environment. Proper care extends the unit’s lifespan and ensures optimal therapy delivery. Always follow the manufacturer’s guidelines for maintenance and handling to maintain its effectiveness and safety. This ensures continuous, reliable operation during the healing process.
7.2 Patient Mobility and Activity
The Prevena Plus 125 is designed to promote patient mobility while ensuring continuous therapy. Patients can move freely, with the lightweight unit secured under clothing. Avoid strenuous activities that may dislodge the dressing. Showering is possible with the unit, but precautions should be taken to prevent water exposure to the therapy unit. Regular movement helps maintain therapy effectiveness, but always ensure the unit is properly secured to avoid leaks or interruptions. Consult your healthcare provider for activity recommendations tailored to your condition.
7.3 Showering and Sleeping with the Device
Showering with the Prevena Plus 125 is possible, but ensure the therapy unit remains dry. Cover or seal the unit to prevent water exposure. When sleeping, secure the device under clothing or in a carrying case to avoid displacement. Avoid submerging the unit in water, as this may damage it. Patients can sleep comfortably with the device, but ensure proper placement and connection. Follow manufacturer guidelines for showering and sleeping to maintain therapy effectiveness and patient comfort.
7.4 Monitoring for Adverse Reactions
Clinicians and patients should monitor for signs of adverse reactions, such as increased pain, redness, or swelling at the surgical site. Ensure the dressing is applied correctly to prevent skin irritation or allergic reactions. Regularly inspect the incision and surrounding area for any unusual changes. If any adverse reactions occur, discontinue therapy and consult a healthcare professional immediately. Proper monitoring ensures the effectiveness of the Prevena Plus 125 and minimizes potential complications.
Disposal and Replacement
Dispose of the used Prevena Plus 125 Therapy Unit and dressing according to local medical waste regulations. Replace the dressing as instructed by your healthcare provider.
8.1 Proper Disposal of the Therapy Unit
Dispose of the Prevena Plus 125 Therapy Unit and its components according to local medical waste regulations. Ensure the battery is removed and disposed of separately.
Do not incinerate the device, as it may contain electronic components. Properly seal the unit in a biohazard bag before disposal. For home use, follow the instructions provided by your healthcare provider or local waste management guidelines. Always prioritize environmentally responsible disposal methods to minimize potential hazards.
8.2 Replacing the Dressing
To replace the Prevena Plus 125 dressing, first ensure the therapy unit is turned off. Gently remove the old dressing, taking care not to disturb the surgical site. Inspect the area for any signs of leakage or irritation. Dispose of the used dressing according to medical waste guidelines. Apply the new dressing by aligning it with the incision site and securing it firmly. Ensure the dressing is properly connected to the therapy unit and check for any leaks using the Visicheck feature. Reactivate the unit and monitor for proper function.
8.3 Transitioning to Home Care
Transitioning to home care with the Prevena Plus 125 requires thorough patient education. Ensure the patient or caregiver understands device operation, including turning it on/off, monitoring therapy, and responding to alerts. Provide clear, written instructions and emergency contact details. Demonstrate how to check for leaks and replace dressings if necessary. Confirm the patient can manage the device independently before discharge. Schedule follow-up appointments to assess healing progress and address any concerns.
Regulatory Information and Compliance
The Prevena Plus 125 complies with FDA and CE regulatory standards, ensuring safety and effectiveness. It is designed for use in controlled electromagnetic environments and adheres to ISO medical device standards.
9.1 FDA and CE Markings
The Prevena Plus 125 Therapy Unit is FDA-cleared and CE-marked, ensuring compliance with U.S. and European medical device regulations. These certifications confirm the device meets rigorous safety and performance standards for wound therapy. The FDA clearance indicates adherence to U.S. medical device requirements, while the CE marking demonstrates conformity with EU directives. Both markings ensure the device is safe and effective for its intended use in wound healing and incision management; Proper use in accordance with the instructions is essential to maintain compliance and ensure patient safety.
9.2 Compliance with Medical Standards
The Prevena Plus 125 Therapy Unit complies with international medical standards, ensuring safety and effectiveness. It adheres to strict regulatory requirements, including ISO standards for medical devices. Regular testing and quality assurance processes guarantee reliability and performance. Compliance with these standards ensures the device meets global expectations for wound therapy, providing patients and healthcare professionals with a trusted solution for incision management. Adherence to medical standards is critical for maintaining the integrity and effectiveness of the therapy unit.
9.3 User Responsibilities
Users of the Prevena Plus 125 must adhere to specific responsibilities to ensure safe and effective therapy. This includes following all instructions in the manual, monitoring the device for proper function, and reporting any issues to healthcare providers. Patients should avoid modifying the unit or using unauthorized accessories. Regular checks for leaks, battery life, and dressing integrity are essential. Compliance with these responsibilities helps maintain optimal therapy outcomes and minimizes potential risks. Proper handling and care are vital for achieving successful wound healing and patient safety.